Nicotine DependenceNCT00844701
Cue Induced Imaging in Nicotine Dependent Smokers
An observational study of Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relationship between craving to smoke and areas activated in brain. The researchers are using functional magnetic resonance imaging (MRI) that measures brain blood flow, or perfusion, to study this brain activation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: adult nicotine dependent smokers
Who may be able to join
- Age 18 - 60.
- Participants will meet criteria for primary nicotine dependence, smoke at least 70% of days in the last 30 days prior to assessment.
- Able to read and understand questionnaires and informed consent.
- Right-handed.
- Currently is not engaged in, and does not want, treatment for nicotine related problems.
- Able to maintain abstinence from nicotine during the study period.
Show all 12Show fewer
- Participants must have a negative rapid-screening UDS and pregnancy test prior to imaging session.
- Age 18 - 60.
- Does not meet the DSM-IV criterion for lifetime or current substance dependence.
- Has used tobacco products no more than on experimental basis (none in past year).
- Participants must have a negative rapid-screening UDS and pregnancy test prior to session.
- Righthanded.
Who cannot join
- Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
- Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
- Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. The rationale for excluding them is that symptoms from these disorders may affect dependent variables and complicate interpretation of the data.
- Has current suicidal ideation with plan or homicidal ideation.
- Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
- Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit ability to participate in scan.
Show all 9Show fewer
- Sexually active females of child-bearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
- Has current charges pending for a violent crime (not including DUI related offenses).
- Persons with ferrous metal implants or pacemaker since fMRI will be used.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Validation of Cue Induced Imaging Paradigm in Nicotine Dependent Smokers
The purpose of this study is to evaluate the relationship between craving to smoke and areas activated in brain. The researchers are using functional magnetic resonance imaging (MRI) that measures brain blood flow, or perfusion, to study this brain activation.
Read the detailed description
Functional magnetic resonance imaging has demonstrated that the same types of environmental cues that induce craving activate an integrated network of brain areas involved in the appetitive and motivational process of addiction to drugs of abuse including nicotine ( Brieter 119; Koob 2001, Volkow 2003).In nicotine deprived smokers both mesolimbic dopamine reward pathways (amygdala, ventral tegmental area, and medial thalamus) and areas related to visuospatial attention (bilateral prefrontal cortex and parietal cortex and right fusiform gyrus) are activated by exposure to smoking images (Due 2002, David 2005).
In line with the National Institute on Drug Abuse's (NIDA) emphasis on novel methods for investigating substance use disorders, the current study proposes to use fMRI to better understand the neurological correlates of cue reactivity among nicotine dependent smokers. This approach will permit the isolation of pathways that are relevant to cue induced craving.
- Conditions
- Nicotine Dependence
- Keywords
- nicotine, addiction, fMRI, neuroimaging, neurobiology, craving
- Medical subject headings
- Tobacco Use Disorder, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-smoker | Non-smoking control | |
| Nicotine Dependent Smoking Group | current smokers |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Karen Hartwell, MD, Principal investigator, Medical Universtiy of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844701
- Sponsor's protocol ID
- BOLD fMRI
- Status last verified
- Oct 2009
- First submitted
- 12 Feb 2009
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Cue Induced Imaging Paradigm in Nicotine Dependent Smokers
- ClinicalTrials.gov ID
- NCT00844701
- Acronym / sponsor ID
- BOLD fMRI
- Conditions
- Nicotine Dependence
- Keywords
- nicotine, addiction, fMRI, neuroimaging, neurobiology, craving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relationship between craving to smoke and areas activated in brain. The researchers are using functional magnetic resonance imaging (MRI) that measures brain blood flow, or perfusion, to study this brain activation.
Detailed description
Functional magnetic resonance imaging has demonstrated that the same types of environmental cues that induce craving activate an integrated network of brain areas involved in the appetitive and motivational process of addiction to drugs of abuse including nicotine ( Brieter 119; Koob 2001, Volkow 2003).In nicotine deprived smokers both mesolimbic dopamine reward pathways (amygdala, ventral tegmental area, and medial thalamus) and areas related to visuospatial attention (bilateral prefrontal cortex and parietal cortex and right fusiform gyrus) are activated by exposure to smoking images (Due 2002, David 2005).
In line with the National Institute on Drug Abuse's (NIDA) emphasis on novel methods for investigating substance use disorders, the current study proposes to use fMRI to better understand the neurological correlates of cue reactivity among nicotine dependent smokers. This approach will permit the isolation of pathways that are relevant to cue induced craving.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-smoker | – | –Non-smoking control |
| Nicotine Dependent Smoking Group | – | –current smokers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adult nicotine dependent smokers
Key inclusion criteria (12 listed)
- Age 18 - 60.
- Participants will meet criteria for primary nicotine dependence, smoke at least 70% of days in the last 30 days prior to assessment.
- Able to read and understand questionnaires and informed consent.
- Right-handed.
- Currently is not engaged in, and does not want, treatment for nicotine related problems.
Key exclusion criteria (9 listed)
- Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
- Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
- Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. The rationale for excluding them is that symptoms from these disorders may affect dependent variables and complicate interpretation of the data.
- Has current suicidal ideation with plan or homicidal ideation.
- Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
Related trials for Nicotine Dependence
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
Recruiting
Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke
Smoking Cessation, Depression
Not yet recruitingPhase 2
Effects of Psilocybin on Craving in Nicotine Dependence
Nicotine Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Hartwell, MD principal investigator
Medical Universtiy of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.